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OpenTrials
Completed

NCT Number: NCT00761930

Compare the Clinical Efficacy of Prototype Toothpastes.

Evaluate clinical efficacy of a prototype toothpaste on control of dental plaque gingival inflammation

Completed

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Eastman Dental Center - University of Rochester

Rochester, New York, 14642-8315, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female volunteers 18-65 years of age
  • Good general health
  • Must sign informed consent form
  • Minimum of 16 natural uncrowned teeth (excluding third molars) must be present.
  • No history of allergy to personal care consumer products, or their ingredients,
  • relevant to any ingredient in the test products as determined by the dental/medical
  • Professional monitoring the study.
  • Dental Selection Criteria: Average full mouth GI score should be in the range of
  • - 2.0. heavy plaque formers should be avoided. Target a full mouth PI
  • (Quigley-Hein) to be in the range of 1.5-3.0
  • If of child bearing potential and on birth control (diaphragm, birth control pills,
  • Birth control implants, IUD (Intrauterine device), condoms)

Exclusion criteria

  • Subjects unable or unwilling to sign the informed consent form.
  • Medical condition which requires pre-medication prior to dental visits/procedures
  • Moderate or advanced periodontal disease
  • 2 or more decayed untreated dental sites at screening.
  • Other disease of the hard or soft oral tissues.
  • Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
  • Use of medications that are currently affect salivary flow.
  • Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
  • Pregnant or nursing women.
  • Participation in any other clinical study within 1 week prior to enrollment into this
  • study.
  • Use of tobacco products
  • Subjects who must receive dental treatment during the study dates.
  • Current use of Antibiotics for any purpose.
  • History of allergy to common dentifrice ingredients
  • Presence of an orthodontic appliance which interferes with plaque scoring.
  • History of allergy to natural remedies, such as herbal ingredients
  • Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
  • Smoker

Treatment and study plan

Fluoride

Drug

Brush twice daily

Other names: Colgate Great Regular Flavor toothpaste

Triclosan and fluoride

Drug

Brush twice daily

Other names: Colgate Total toothpaste

Herbal Ingredient and fluoride

Drug

Brush twice daily

Primary outcomes

  1. Dental Plaque

    Time frame: 6 weeks

    Quigley Hein Method: Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth. Plaque score= sum of all scores divided by the number of sites (teeth) scored.

  2. Gingivitis Score

    Time frame: 6 weeks

    Gingivitis score (GI)= Units on a scale 0 to 3 (0 = no inflammation,

    1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding. GI scored=sum of GI scores divided by the number of sites (gingival gum line around the tooth)scored.

  3. Bleeding Index (EIBI)

    Time frame: 6 weeks

    Eastman Interdental Bleeding Index Scores (EIBI) measures the number of interdental spaces that bleed, divided by number of interdental spaces studied to yield a score with a minimum of O and a maximum of 1 (0=no bleeding & 1= bleeding) The number of spots between teeth that bleed are divided by number of spots between teeth that are scored and may be expressed as a percent when multiplied by 100.

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Sep 30, 2008
Registry last updated
Aug 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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